Drive Mechanism for an Autoinjector

ABSTRACT

The present invention relates to a drive mechanism for use with a medicament delivery device, comprising a plunger rod ( 68 ), a drive spring ( 72 ) operably arranged to the plunger rod, an actuator ( 52 ) comprising a holding member ( 60 ) releasably engaged to the plunger rod ( 68 ) for holding said plunger rod ( 68 ) with said drive spring ( 72 ) in a tensioned state, a rotator ( 38 ) operably connected and movable relative to said actuator ( 52 ) and configured to interact with said holding member for holding said holding member in engagement with the plunger rod, an activator ( 30 ) operably connected to said rotator ( 38 ). The invention is characterized in that the activator ( 30 ) is configured to rotate and subsequently linearly displace the rotator ( 38 ) in relation to the actuator ( 52 ) such that said holding member ( 60 ) is released from the plunger rod ( 68 ).

The present invention relates to a drive mechanism for medicamentdelivery devices and in particular medicament delivery devices providedwith a high degree of automated functions.

BACKGROUND OF INVENTION

There is a constant development of medicament delivery devices that areintended and designed to be used and handled by users that are notqualified nursing staff or physicians, i.e. handled by the patientsthemselves. The applicant of the present invention has developed a largenumber of medicament delivery devices that display a high degree ofautomated functions comprising mixing of drug, priming, penetration,injection withdrawal and/or extension of medicament delivery memberguard.

In order to create a number of these functions while keeping the numberof components as low as possible, a so called rotator has often beenutilized, which is a generally tubular element that is capable ofrotating inside the housing of a medicament delivery device, where therotation triggers, enables and/or performs different functions.

Document WO2011/123024 discloses a medicament delivery device arrangedwith such a rotator. The rotator is operated by a medicament deliverymember guard during penetration sequence. The rotator in turn affectsholding elements that holds a plunger rod in a tensioned state. Theholding elements are in the form of arms provided with inwardly directedprotrusions fitting into recesses of the plunger rod.

When the rotator has turned a certain rotational angle, wherein thepenetration sequence is completed, the holding members are released fromthe rotator, whereby the plunger rod also is freed and is moved in theproximal direction for delivering a dose of medicament. The rotator alsohas additional features such as locking of the medicament deliverymember guard in an extended position after removal of the medicamentdelivery device after injection.

Even though the rotator solution works very well in most instances andprovides a reduced number of components as compared to more conventionalsolutions, there have been occurrences when the rotational movement ofthe rotator has caused a bending of the holding members due to thefriction between the rotator and the holding members. This in turn hasled to a jamming of the holding members such that the plunger rod hasnot been released as it should.

BRIEF DESCRIPTION OF INVENTION

The aim of the present invention is to remedy the drawbacks of the stateof the art drive mechanisms. This aim is obtained by a drive mechanismfor a medicament delivery device having the features of the independentpatent claims. Preferable embodiments are found in the dependent patentclaims.

The present invention relates to a drive mechanism for use with amedicament delivery device. The drive mechanism preferably comprises aplunger rod and a drive spring operably arranged to plunger rod whereinthe plunger rod is arranged to act on a stopper arranged in a medicamentcontainer.

The drive mechanism may further be arranged with an actuator comprisinga holding member releasably engaged to the plunger rod for holding saidplunger rod with said drive spring in a tensioned state. Also a rotatoris operably connected and movable relative to said actuator andconfigured to interact with said holding member for holding said holdingmember in engagement with the plunger rod.

Further, an activator may be operably connected to the rotator, in thatthe activator is configured to rotate and subsequently linearly displacethe rotator in relation to the actuator such that holding member isreleased from the plunger rod. With this solution it is possible toavoid the previous problems associated with the rotation of the rotatorprior to unlocking of the actuator, because the final movement is alinear movement. The risk of jamming of the holding members is thenavoided or at least substantially reduced.

In order to control the movement of the rotator, the actuator may bearranged with a guide surface on which the rotator rests when rotatedfrom a first position to a second position. In order to further controlthe movement of the rotator, it may be arranged with a cut-out, in whichthe guide surface can enter in the second position for allowing a linearmove of the rotator. Thus, in the rotational movement between the firstand the second position, the rotator is guided by the guide surface,preventing any linear movement, and then in the second position, thelinear movement is provided in that the guide surface enters thecut-out.

In order to provide a rotational movement, the rotator may comprisefirst guide ridges that are inclined in relation to a longitudinaldirection, on which first guide ridges the activator acts for rotatingsaid rotator. Thus the inclined surface provides the means for rotatingthe rotator from the first position to the second position.

The rotator may further comprise second guide ridges interconnected tothe first guide ridges, wherein the second guide ridges are generallytransversal in relation to the longitudinal direction, on which secondguide ridges the activator may act for moving said rotator.

In order to obtain the right relative initial positions between therotator and the actuator, the rotator may comprise first orientatingelements operably arranged to interact with second orientating elementson the actuator for providing orientation aid when the rotator isassembled with the actuator.

According to one feasible solution, the first orientating elements maycomprise longitudinal grooves and wherein the second orientatingelements comprise protrusions arranged to fit into the longitudinalgrooves. This enables a proper orientation when the rotator is pushedonto the actuator during assembly of the drive mechanism, reducing therisk of rotational misalignment of the rotator in relation to theactuator.

In order to further provide aid when assembling the drive mechanism, itmay further comprise a stop recess on the rotator, in which stop recessthe protrusion would fit when the rotator is attached to the actuator.This gives a clear indication that the rotator has been pushed onto theactuator properly. This may also be used as a stop member in theopposite direction, i.e. preventing pulling off of the rotator from theactuator.

According to one feasible solution, the activator may comprise amedicament delivery member guard. Since the medicament delivery memberguard is arranged at the proximal end of a medicament delivery device,it may move distally when the medicament delivery device is pressedagainst a dose delivery site, which movement may be used for rotatingand moving the rotator.

These and other aspects of, and advantages with, the present inventionwill become apparent from the following detailed description of theinvention and from the accompanying drawings.

BRIEF DESCRIPTION OF DRAWINGS

In the following detailed description of the invention, reference willbe made to the accompanying drawings, of which

FIG. 1 is an exploded view of one embodiment of a medicament deliverydevice,

FIGS. 2a, b are cross-sectional side views of the device of FIG. 1,

FIGS. 3 to 5 are detailed views of components comprised in the device ofFIG. 1, and

FIGS. 6 to 10 are detailed views of the device of FIG. 1 in differentfunctional states.

DETAILED DESCRIPTION OF THE INVENTION

In the following description, the wording medicament delivery devicewill be used. In this context, medicament delivery devices may include anumber of devices capable of delivering certain doses of medicament to auser, such as e.g. injection devices with or without injection needles,inhalers of all kinds, such as powder, aerosol driven, gas, nebulizershaving mouth or nasal pieces, dispensers for medicament in tablet form,eye dispensers, creme/gel dispensers, etc. The medicament deliverydevices may be of either disposable type or re-usable type and may beprovided with medicament containers suitably arranged for specific drugsin specific forms.

Further, the term “distal part/end” refers to the part/end of thedevice, or the parts/ends of the members thereof, which under use of thedevice, is located the furthest away from a delivery site of a patient.Correspondingly, the term “proximal part/end” refers to the part/end ofthe device, or the parts/ends of the members thereof, which under use ofthe device is located closest to the delivery site of the patient.

The medicament delivery device shown in the drawings comprises agenerally tubular elongated housing 10 having a distal end 12 and aproximal end 14, FIG. 1. The housing 10 is further arranged with windowsor openings 16, through which a medicament container 18 can be viewed.The medicament container 18 is arranged with a movable stopper 20. Thedevice further comprises a medicament container holder 22 having agenerally tubular shape, FIG. 1. The medicament container holder 22 isarranged to accommodate the medicament container 18, where themedicament container 18 has a proximal end on which a medicamentdelivery member 24, FIG. 2, is arranged, either made integral orconnectable to the medicament container 18. The medicament deliverymember 24 is preferably protected before use by a medicament deliverymember shield 26 that in the embodiment shown is a so called rigidneedle shield or RNS. It is however to be understood that other types ofmedicament delivery member shields may be used in order to obtain thedesired protection of the medicament delivery member 24.

The proximal end of the housing is arranged with a central passage 28,FIG. 1, through which an activator 30 extends. In the present embodimentthe activator 30 is a generally tubular medicament delivery memberguard. The medicament delivery member guard 30 is in this embodiment anactivation mechanism of a drive mechanism comprised in the medicamentdelivery device. It is arranged slidable i.e. linearly movable inrelation to the housing 10 such that the housing 10 with the medicamentcontainer 18 and the medicament delivery member 24 are moved in theproximal direction when the medicament delivery device is pressedagainst a dose delivery site, thereby exposing the medicament deliverymember 24 such that a penetration is performed when the medicamentdelivery member is an injection needle.

The activator 30 comprises a proximal tubular 32 part and two distallydirected arms 34 extending from the tubular part 32. A medicamentdelivery member guard spring 35 is arranged between a distally directedcircumferential wall part of the activator 30 and a proximally directedcircumferential surface of the housing. The arms 34 are arrangedslidable along the medicament container holder 22. At the distal end ofthe arms 34, inwardly directed protrusions 36 are arranged. Theprotrusions 36 are arranged to operably interact with a rotator 38,FIGS. 3 and 4, of a drive mechanism comprised in the medicament deliverydevice, when the activator 30 is moved in relation to the housing,wherein the rotator 38 is positioned distally of the medicamentcontainer 18.

The rotator 38 has a generally tubular shape and is arranged with guideridges 42, FIG. 4, that are intended to cooperate with the protrusions36 of the activator 30. The guide ridges comprise a first guide ridge 42_(i) that is inclined in relation to the longitudinal axis L of thedevice, which inclined first guide ridge interconnects with a roundedsecond guide ridge 42 _(r) as seen in FIG. 4 where the second guideridge 42 _(r) is generally transversal to the longitudinal axis L. Athird guide ridge 42 _(l) is connected to the second guide ridge, wherethe third guide ridge 42 _(l) is extending in the longitudinaldirection. The functions of the guide ridges will be described below.Adjacent the third guide ridge 42 _(l) are proximally directed tongues44, which tongues 44 are arranged with wedge-shaped outwardly directedledges 46. Further, the rotator is arranged with cut-outs 48 at itsdistal end surface. Inside the rotator, support surfaces 50 arearranged. Further inside the rotator 38, orientating elements in theform of longitudinal grooves 51 are arranged, from a distal end toalmost the proximal end. However, the groove 51 terminates a distancefrom the proximal end. At the edge of the proximal end in the directionof the longitudinal groove a cut-out 53, forming a stop recess, is made.

An actuator 52, FIGS. 3 and 5, is in this embodiment a part of the drivemechanism comprised in the medicament delivery device, The actuator 52is further arranged operably to the rotator 38. It comprises a firstproximal tubular section 54 having a diameter slightly smaller than theinner diameter of the rotator 38. It further comprises a second section56 arranged to fit into and to be attached to a distal part of thehousing 10. The second section 56 is provided with proximally directedledges 58 arranged to interact with the rotator as will be described.The second section is further arranged with proximally directed stopsurfaces 59, FIG. 5.

The first section 54 is further arranged with holding members 60 whichin the present embodiments are proximally extending arms that arearranged flexible in a generally radial direction. The free ends of theholding members 60 have outwardly extending protrusions 62 that are tointeract with the guide surfaces 50 of the rotator 38 as will bedescribed. Further the free ends of the holding members 60 are arrangedwith inwardly extending protrusions 64, which protrusions 64 areintended to interact with recesses 66 on a generally tubular plunger rod68, FIG. 3. The generally tubular plunger rod 68 is in this embodiment apart of the drive mechanism comprised in the medicament delivery device.The protrusions 64 extend into a central passage 70 of the actuator 52,in which passage 70 the plunger rod 68 fits. Further, outwardlydirected, generally wedge-shaped, protrusions 71 are arranged adjacentthe passage 70.

A drive spring 72 which is in this embodiment a part of the drivemechanism comprised in the medicament delivery device, is placed insidea cavity of the hollow plunger rod 68, wherein the drive spring 72 ispositioned with a proximal end thereof in contact with an end wall 74 ofthe plunger rod 68, FIG. 2. The distal end of the drive spring 72 is incontact with a generally U-shaped element, hereafter named activator 76,having a base 78 and two arms 80, FIG. 3. The arms 80 of the activator76 are directed in the proximal direction along, and in contact with,the outer surface of the plunger rod 68, wherein the free ends of thearms 80 are arranged with generally radially outwardly directed ledges82. These ledges 82 are arranged to be in contact with a proximallydirected surface 84, FIG. 5, surrounding the central passage 70 of theactuator 52.

The medicament delivery device is further arranged with a protective cap86, FIGS. 1 and 2, having a shape as to be releasably attached to theproximal end of the housing. The protective cap 86 is further arrangedwith a medicament delivery member shield remover 88 that in theembodiment shown has a generally tubular shape with a diameter so as toextend into the activator and surround the medicament delivery membershield 26. The medicament delivery member shield remover 88 is arrangedwith grip elements 90 that are inwardly inclined, proximally directedtongues that are capable of gripping into the surface of the medicamentdelivery member shield when the protective cap is pulled in the proximaldirection in relation to the medicament delivery device.

The device is intended to function as follows. When the medicamentdelivery device is delivered to a user, a medicament container 18 withan attached medicament delivery member shield 26 has been placed in themedicament container holder 22 and a protective cap has been attached tothe proximal end of the medicament delivery device. The drive spring 72has been tensioned in that the plunger rod 68 has been pushed distallyrelative the actuator 52 such that the inwardly directed protrusions 64of the holding members 60 of the actuator 52 engage with the recesses 66of the plunger rod 68, thereby holding the plunger rod 68.

The rotator 38 is then pushed axially onto the actuator 52 from theproximal end. In order have the right rotational orientation of therotator in relation to the actuator 52, the rotator 38 is held such thatthe orientating elements, i.e. the protrusions 71, will fit in thelongitudinal grooves 51 of the rotator 38. The rotator 38 is then pushedaxially until the protrusions 71 fit into the cut-outs 53, whichprevents pulling back of the rotator 38. In this rotational position,named first position, the distally directed end of the rotator 38 is incontact with the ledges 58 of the actuator 52 as seen in FIG. 6. Theholding members 60 of the actuator 52 are now prevented from moving outof engagement by the support surfaces 50 of the rotator 38 in contactwith the outwardly directed protrusions 62 of the holding members 60.

When a dose of medicament is to be delivered, the protective cap 86 isremoved from the proximal end of the medicament delivery device bypulling it in the proximal direction. Because of the engagement of thetongues 90 with the medicament delivery member shield 26, the medicamentdelivery member shield 26 will also be pulled in the proximal direction,removed from the medicament delivery member 24. The proximal end of themedicament delivery device is then pressed against a dose delivery site.This causes the activator 30 to move inside and relative the housing 10.This in turn causes the protrusions 36 of the activator 30 to move alongthe guide ridges 42 of the rotator 38 such that the protrusions willcome in contact with the first guide ridge 42 _(i), which will cause therotator 38 to turn around the longitudinal axis L of the device i.e. torotate.

The turning/rotation of the rotator 38 will cause its distally directedend surface to slide along the ledges 58 as seen in FIG. 7 until theprotrusions 36 have reached the second guide ridge 42 _(r). At the sametime, in this second position, the cut-outs 48 of the rotator 38 havereached the ledges 58, FIG. 8, so that further pushing of the activator30 will cause the rotator 38 to move axially i.e. to be linearlydisplaced in the distal direction with its support surfaces sliding inrelation to the outwardly directed protrusions of the arms of theactuator. The axial movement of the rotator 38 is stopped when itsdistally directed end surface abuts the proximally directed stop surface59 of the actuator. At this third position, the outwardly directedprotrusions 62 of the holding members 60 of the actuator 52 have passeda proximal end surface of the rotator 38, FIG. 9, and have thus movedout of contact with inner surfaces of the rotator 38. The holdingmembers 60 of the actuator 52 are now free to flex outwardly, wherebythe inwardly directed protrusions 64 of the holding members 60 are movedout of contact with the recesses 66 of the plunger rod 68.

The flexing of the holding members 60 is rapid and outer surfaces of theholding members 60 will hit the rotator 38, causing an audible andtactile signal that the dose delivery sequence has started. The plungerrod 68 is now free to move in the proximal direction due to the force ofthe drive spring 72, wherein the proximal end of the plunger rod 68 actson, and moves, the stopper 20 inside the medicament container 18 in theproximal direction such that a dose of medicament is expelled throughthe medicament delivery member 24.

When the stopper 20 has been moved by the plunger rod 68 to almost theproximal end inside the medicament container 18, the plunger rod 68 ismoved out of contact with the arms 80 of the signalling element 76. Thearms 80 of the signalling element 76 are thus free to flex inwards suchthat the ledges 82 are moved out of contact with the surfaces 84 of theactuator 52, and due to the force of the drive spring 72 in contact withand acting on the base 78 of the signalling element 76, the signallingelement 76 will be moved suddenly in the distal direction the distance Duntil the distal end of the signalling element 76 hits a proximallydirected end wall of the actuator, thus providing an audible and tactilesignal that the dose delivery sequence is completed and that it is safeto remove the medicament delivery device. It may now be discarded in asafe manner.

It is to be understood that the embodiments described above and shown inthe drawings are to be regarded only as non-limiting examples of theinvention and that it may be modified in many ways within the scope ofthe patent claims.

1-10. (canceled)
 11. Drive mechanism for use with a medicament deliverydevice, comprising a plunger rod, a drive spring operably arranged tothe plunger rod, an actuator comprising a holding member releasablyengaged to the plunger rod for holding said plunger rod with said drivespring in a tensioned state, a rotator operably connected and movablerelative to said actuator and configured to interact with said holdingmember for holding said holding member in engagement with the plungerrod, an activator operably connected to said rotator, wherein theactivator is configured to rotate and subsequently linearly displace therotator in relation to the actuator such that said holding member isreleased from the plunger rod.
 12. Drive mechanism according to claim11, wherein said actuator is arranged with a guide surface on which saidrotator rests when rotated.
 13. Drive mechanism according to claim 12,wherein said rotator is arranged with a cut-out, in which said guidesurface can enter for allowing the subsequently linearly displacement ofthe rotator in relation to the actuator.
 14. Drive mechanism accordingto claim 11, wherein said rotator comprises first guide ridges that areinclined in relation to a longitudinal direction, on which first guideridges said activator acts for rotating said rotator.
 15. Drivemechanism according to claim 14, wherein said rotator comprises secondguide ridges interconnected to said first guide ridges.
 16. Drivemechanism according to claim 15, wherein the second guide ridges aregenerally transversal in relation to the longitudinal direction (L), onwhich second guide ridges said activator acts for moving said rotator.17. Drive mechanism according to claim 11, wherein said rotatorcomprises first orientating elements operably arranged to interact withsecond orientating elements on said actuator for providing orientationaid when said rotator is assembled with said actuator.
 18. Drivemechanism according to claim 17, wherein said first orientating elementscomprise longitudinal grooves.
 19. Drive mechanism according to claim18, wherein said second orientating elements comprise protrusionsarranged to fit into said longitudinal grooves.
 20. Drive mechanismaccording to claim 19, further comprising a stop recess on the rotator,in which stop recess said protrusion would fit when said rotator isattached to said actuator.
 21. Drive mechanism according to claim 11,wherein said activator is a medicament delivery member guard. 22.Medicament delivery device comprising a drive mechanism according toclaim
 11. 23. Drive mechanism according to claim 11, wherein the plungerrod comprises a hollow plunger rod defining a cavity.
 24. Drivemechanism according to claim 21, wherein the drive spring is placedinside the cavity defined by the plunger rod.
 25. Drive mechanismaccording to claim 11, wherein the actuator comprises at least one guideridge that is suitable for cooperating with a protrusion of theactivator.
 26. Drive mechanism according to claim 11, wherein theactivator extends through a central passage of a housing.
 27. Drivemechanism according to claim 26, wherein that activator is arrangedslidable in relation to the housing.
 28. Drive mechanism according toclaim 27, further comprising a guard spring arranged between a distallydirected circumferential wall part of the activator and a proximallydirected circumferential surface of the housing.
 29. Drive mechanismaccording to claim 11, wherein the actuator comprises a proximal tubularpart and a first and a second distally directed arm extending from thetubular part.
 30. Drive mechanism according to claim 26, furthercomprising a container holder fixed to the housing.